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Scheduling delegate's final decisions, January 2018
Scheduling medicines and poisons
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of peramivir, a new chemical entity (NCE) for a human therapeutic medicine.
Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and is also important for viral entry into uninfected cells, which causes further spread of infectious virus in the body.
The antiviral activity of peramivir against laboratory strains and clinical isolates of influenza virus was determined in cell culture. The concentrations of peramivir required for inhibition of influenza virus in cell culture varied depending on the assay method used and the virus tested.
Peramivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children 2 years and older. Treatment should commence as soon as possible, but no later than 2 days after the onset of the initial symptoms of infection.
|Molecular weight||382.5 g/mol|
|Chemical names||(1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-(carbamimidoylamino)-2hydroxycyclopentanecarboxylic acid,trihydrate|
|Other names||111346 (eBS ID); Peramivir (ANN/INN)|
Peramivir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)) as follows:
Peramivir is classified as a prescription medicine in Canada, United States of America and the European Union.
The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (2015) scheduling factors; and
- The TGA evaluation report.
- The new drug application
The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.
Delegate’s final decision
The delegate has made a final decision to amend the Poisons Standard to include insulin degludec in Schedule 4, with an implementation date of 1 February 2018.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 – New Entry
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
The delegate decided that the reasons for the final decision comprise the following:
- Peramivir is a new chemical entity with no clinical or marketing experience in Australia.
- Peramivir is to be used for the treatment of infections due to influenza A and B viruses. Treatment should commence as soon as possible, but no later than 2 days after the onset of the initial symptoms of infection.
- The adverse events include insomnia, liver function abnormality, abnormal behaviour, skin reactions, hypertension, etc.
- Peramivir is for intravenous infusion.